| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2822873 | 72 | F | TN | 01/26/2025 |
FLU3 |
SANOFI PASTEUR |
u0524da |
Pruritus, Rash
Pruritus, Rash
|
Patient states she went to bed the evening of receiving vaccine and she had a rash on her upper ches...
Patient states she went to bed the evening of receiving vaccine and she had a rash on her upper chest/trunk and neck that was itching. When she woke up the next morning, it had spread more and was itching way worse.
More
|
||||||
| 2822874 | 70 | F | OR | 01/26/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
5J959 |
Injection site discolouration, Injection site erythema, Injection site hypersens...
Injection site discolouration, Injection site erythema, Injection site hypersensitivity
More
|
Patients husband reported red, flush, warm and sensitive round area at site of injection. Patients h...
Patients husband reported red, flush, warm and sensitive round area at site of injection. Patients husband was reporting that the shot had happened two days prior and patient was doing well.
More
|
||||||
| 2822875 | 75 | M | MT | 01/26/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EL9266 EL9266 EL9266 EL9266 EL9266 EL9266 FD7220 FD7220 FD7220 |
Bladder cancer, Bladder scan, Breast mass, Discouragement, Dyspepsia; Dyspnoea, ...
Bladder cancer, Bladder scan, Breast mass, Discouragement, Dyspepsia; Dyspnoea, Exercise tolerance decreased, Fatigue, Pulmonary fibrosis, Ventilation/perfusion scan; Weight decreased; Bladder cancer, Bladder scan, Breast mass, Discouragement, Dyspepsia; Dyspnoea, Exercise tolerance decreased, Fatigue, Pulmonary fibrosis, Ventilation/perfusion scan; Weight decreased; Bladder cancer, Bladder scan, Breast mass, Discouragement, Dyspepsia; Dyspnoea, Exercise tolerance decreased, Fatigue, Pulmonary fibrosis, Ventilation/perfusion scan; Weight decreased
More
|
SHORTNESS OF BREATH - HIKES BECOME SHORTER AND SHORTER , WEIGHT LOSS, FATIGUE AND DISCOURGED HE COUL...
SHORTNESS OF BREATH - HIKES BECOME SHORTER AND SHORTER , WEIGHT LOSS, FATIGUE AND DISCOURGED HE COULD NO LONGER HIKE, LUMP IN BREAST, TERRIBLE INDIGESTION DIAGNOSIS OF PULMONARY FIBROSIS AND FAST MOVING BLADDER CANCER.
More
|
โ | |||||
| 2822876 | 53 | F | FL | 01/26/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
N77J2 |
Injection site cellulitis, Injection site reaction, Rash erythematous
Injection site cellulitis, Injection site reaction, Rash erythematous
|
Patient developed a red rash around the injection site on her right arm. The rash continued to sprea...
Patient developed a red rash around the injection site on her right arm. The rash continued to spread for 2 days after receiving the injection. Patient saw a physician who determined she has cellulitis, and he has prescribed the patient Doxycycline Hyclate 100mg capsules (one cap twice a day for 7 days).
More
|
||||||
| 2822877 | 17 | F | PA | 01/26/2025 |
COVID19 COVID19 |
NOVAVAX NOVAVAX |
6024MF020 6024MF020 |
Chest pain, Differential white blood cell count, Electrocardiogram, Full blood c...
Chest pain, Differential white blood cell count, Electrocardiogram, Full blood count, Lipase; Metabolic function test, Troponin I
More
|
Sudden and extreme chest pain around 9:30pm. Felt like her organs were being smooshed. Very painful...
Sudden and extreme chest pain around 9:30pm. Felt like her organs were being smooshed. Very painful. Called paramedics. They said vitals were normal but she should get checked out at ED. Went to Hospital. Was tested for many things and then released. The doctor said it might be costochondritis.
More
|
||||||
| 2822878 | 70 | M | FL | 01/26/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
52z52 |
Extra dose administered
Extra dose administered
|
The patient received an additional dose of Arexvy. He did not realize he received the first dose on ...
The patient received an additional dose of Arexvy. He did not realize he received the first dose on 10/4/2023. Patient has received a total of 2 Arexvy doses, when the current CDC guidelines only recommend 1 dose at this time.
More
|
||||||
| 2822879 | 68 | F | CA | 01/26/2025 |
PNC20 |
PFIZER\WYETH |
|
Arthralgia, Pain
Arthralgia, Pain
|
higher than typical localized shoulder pain when applying pressure at injection site starting after ...
higher than typical localized shoulder pain when applying pressure at injection site starting after a few hours. Also upper arm pain around the left shoulder joint when moving the left arm across the body, reaching the arm back to put on a shirt, coat, and raising the arm, etc. No swelling or warmth noticed at injection site. The localized and movement pain now continues more than 6 weeks after the vaccine.
More
|
||||||
| 2822902 | 90 | F | FL | 01/26/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
52Z52 |
Extra dose administered
Extra dose administered
|
patient received an extra dose that does not follow CDC guidelines
patient received an extra dose that does not follow CDC guidelines
|
||||||
| 2822903 | 79 | F | FL | 01/26/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
52Z52 |
Extra dose administered
Extra dose administered
|
PATIENT WAS GIVEN SECOND VACCINE DOSE THAT DOES NOT FOLLOW CDC GUIDELINES
PATIENT WAS GIVEN SECOND VACCINE DOSE THAT DOES NOT FOLLOW CDC GUIDELINES
|
||||||
| 2822904 | 26 | F | CA | 01/26/2025 |
YF |
SANOFI PASTEUR |
UK125AA |
Dizziness, Presyncope
Dizziness, Presyncope
|
Patient received vaccine approximately 1:10pm. Was seated when reported feeling dizzy around 1:15pm....
Patient received vaccine approximately 1:10pm. Was seated when reported feeling dizzy around 1:15pm. I immediately elevated patient's legs, gave the patient some water, and patient reported to start feeling better right after. Patient remained seated with legs elevated for 30 minutes. Patient said never had this kind of reaction to vaccination in the past. Advised patient that this was most likely a vasovagal reaction, and that it can happen to anyone at any point in time in the minutes after any vaccination, regardless of whether or not it happened in the past. Also advised patient to report to primary care doctor what happened and to inform immunizers about dizziness when getting vaccines going forward. Patient felt better and left around 1:45pm without further incident.
More
|
||||||
| 2822905 | 6 | F | WI | 01/26/2025 |
VARCEL |
MERCK & CO. INC. |
Y013347 |
Rash pruritic
Rash pruritic
|
Itchy rash two days later. This also happened to her with two previous vaccines.
Itchy rash two days later. This also happened to her with two previous vaccines.
|
||||||
| 2822906 | 63 | M | FL | 01/26/2025 |
COVID19 |
PFIZER\BIONTECH |
ER2613 |
Blindness, Giant cell arteritis, Headache, Pain in jaw
Blindness, Giant cell arteritis, Headache, Pain in jaw
|
Headaches, jaw discomfort, lose of eye site.
Headaches, jaw discomfort, lose of eye site.
|
โ | |||||
| 2822907 | 56 | F | VA | 01/26/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
014C21A 014C21A |
Amnesia, Cerebral atrophy, Cognitive test, Corticobasal degeneration, Cytogeneti...
Amnesia, Cerebral atrophy, Cognitive test, Corticobasal degeneration, Cytogenetic analysis; Gait disturbance, Lumbar puncture, Magnetic resonance imaging head abnormal, Positron emission tomogram
More
|
About two months after vaccination patient completely lost ability to remember any new information. ...
About two months after vaccination patient completely lost ability to remember any new information. At that time we did not connect this with vaccination. On 12/12/2021 patient received Dose 3 of :Moderna (booster), lot 60H21A In early 2022 we started tests at clinic. MRI scans did not show any damage of patient's brain. In May 2022 patient received wrong (as was shown later) diagnosis of Alzheimer, by Dr of clinic, and started treatment with Donepezil. In Summer 2023 Alzheimer diagnosis was excluded by lumbar puncture at clinic. MRI performed in Sep 2023 have shown about 40% reduction of gray matter volume. doctor gave diagnosis of CorticoBasal degeneration. At the end of 2023, analyzing my notes, I came to conclusion that patient's memory was switched off in 2021 due to Moderna vaccination. In addition to brain atrophy, by 2023 patient also developed severe walking difficulties. The brain atrophy may be the result of wrong treatment with donepezil, while she did not have Alzheimer (there are several scientific papers that show that Donepezil accelerate neurodegeneration in people who do not have Alzheimer). Patient is now completely disables and required 24/7 caregiver support. In 2024 we have followed with clinical trial and study, and with 3-days detailed study at clinic. These studies did not add any more clarity to the reasons of patient's conditions. The doctors at numerous clinics were informed about my conclusion that patient's memory was switched off by mRNA vaccination, but neither deny no confirm this conclusion. I have also conveyed to clinic doctors that the fact that patient's memory was switched off so fast makes patient a new "study Patient"* ๏ฟฝ a person with a known reason that affected her memory mechanism. Genetics, molecular, and other studies of patient may give answers to memory mechanisms questions ๏ฟฝ potentially bringing the Prize to successful researchers. Finding and synthesizing a suitable molecular substance that could switch memory back on ๏ฟฝ would bring a second Prize to courageous scientists. * Different study Patient ๏ฟฝ person whose hippocampus was surgically destroyed and he lost ability to remember new things ๏ฟฝ numerous results on the memory mechanism originated from patient studies.
More
|
โ | |||||
| 2822829 | 50 | F | NH | 01/25/2025 |
VARZOS VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
|
Bladder catheterisation, Bladder scan, Computerised tomogram, Eczema, Hydrourete...
Bladder catheterisation, Bladder scan, Computerised tomogram, Eczema, Hydroureter; Rash, Skin irritation, Urinary hesitation, Urinary retention, Vulvitis; Vulvovaginal pain
More
|
Eczema like rash on arm by 1/5/25. Skin irritation/pain on vulva 1/8 that lasted days. Rash around b...
Eczema like rash on arm by 1/5/25. Skin irritation/pain on vulva 1/8 that lasted days. Rash around both eyes started 1/9. Urinary hesitancy lead to complete inability to void. Catheter placed. Urologist reports inflammation to vulva swelled ureter. Unknown cause
More
|
โ | |||||
| 2822830 | 62 | F | NY | 01/25/2025 |
PNC20 PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH |
|
Cellulitis, Chills, Headache, Injection site pain, Injection site rash; Myalgia,...
Cellulitis, Chills, Headache, Injection site pain, Injection site rash; Myalgia, Nausea, Rash, Rash erythematous, Rash papular; Rash pruritic
More
|
Within 24 hours developed nausea, headache, chills, myalgia, and injection site pain. In 48 hours no...
Within 24 hours developed nausea, headache, chills, myalgia, and injection site pain. In 48 hours noted raised, warm, painful rash below ( not encompassing) injection site and traces of non-painful rash on lateral left breast. Headache and nausea persisted for 48 hours. Went to urgent care at 5 pm on 1/24 as rash had increased in size and intensity (pain, redness). Diagnosed with probable cellulitis and prescribed cephalexin 500 mg TID. Physician did not discuss possibility of shingles. I?ve received 2 zoster vaccines within the last 5 years. On 1/25 8:00 am rash is slightly larger and now itchy and moderately painful. It begins 1-2 inches below injection site in deltoid and covers upper bicep. No vesicles noted.
More
|
||||||
| 2822831 | 80 | F | 01/25/2025 |
RSV |
PFIZER\WYETH |
HY1813 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
Patient received 2 doses of RSV. 1st dose administered was Arexvy 2023 and 2nd dose was Abrysvo 2025...
Patient received 2 doses of RSV. 1st dose administered was Arexvy 2023 and 2nd dose was Abrysvo 2025. Patient reports no adverse effects
More
|
|||||||
| 2822832 | 81 | F | WV | 01/25/2025 |
COVID19 FLU3 VARZOS |
PFIZER\BIONTECH SEQIRUS, INC. GLAXOSMITHKLINE BIOLOGICALS |
LN0591 388487 334T3 |
Mobility decreased, Pain in extremity; Mobility decreased, Pain in extremity; Mo...
Mobility decreased, Pain in extremity; Mobility decreased, Pain in extremity; Mobility decreased, Pain in extremity
More
|
On 1/24/25 at approximately 1:00 pm patient received Shingrix shot in her left arm and Fluad (top) a...
On 1/24/25 at approximately 1:00 pm patient received Shingrix shot in her left arm and Fluad (top) and Comirnaty (bottom) in right arm. I discussed with patient about seperating Shingrix from Fluad and Comirnaty. Patient said she was not going to come back out to get another shot and wanted to get all 3 today. She insisted in 2023 on getting 4 shots together in one day due to the same reason. She stated she was fine with 4 shots and would be fine with 3 shots. I explained that the Shingrix shot had more side effects than the other. She asked did the side effects last forever? I said no it is commonly soreness, achy, fever etc for a couple days. She said she would be fine. Patient received all 3 shots. After receiving the Shingrix shot first she made a comment to the effect of if things keep going this way I was going to be her gal as in the shot didn't hurt. I administered all 3 shots and she did not have any issues while in store. Patient called back after lunch saying she had lost her prescription that she picked up. She did not mention her arm at that time. She called back around 5pm and spoke to the pharmacist on duty, about pain in her arm. Pt stated she had been putting hot compresses on and had taken either IBU or Tylenol. Pharmacist on duty advised her to put cold compress and if not better possibly go to the doctor. Pharmacist on duty asked patient to call back in an hour if not better. Patient did not call back. Around 6:56pm Heatlh System called and spoke to technician, about shots patient received. They requested what immunizations patient received, what arm, manufacture, lot number and expiration date. Dr. electronically sent in prescriptions after we closed for Hydrocodone 5/325 and Lidoderm 5% patch. I spoke with patient around 9:57am on 1/25/25. Right after dialing her number the patients neighbor came to the counter to pick up her prescriptions. Neighbor stated that patient could not move her arm. That doctor last night told her it did not hit a bone, blood vessel or shoulder joint. Neighbor stated she gave her a 5% lidocaine patch and patient stated it did not help any. Patient chose to get OTC 4% patches and the hydrocodone pills. I spoke with patient and she stated she began to hurt after she got home approximately 30 minutes after shot. She stated she has pain in her arm and some in her shoulder. She went to Health System and they told her it was not uncommon to have reactions to Shingrix and that it takes 3-5 days for the pain to go away. She stated she was not going to make it that long and she was going to go to the ER. Patient stated she could move her arm any way she wanted but that it hurt a lot. I repeated about the doctor stating that it wasn't uncommon to have side effects and she stated that he said it wasn't common to have side effects. I asked if she was going to the ER and she stated she would take the medication when her neighbor delivered them and see if they helped. I asked her to contact me later today to let me know how she was or that I can call her and check up. She stated she would give me a call.
More
|
||||||
| 2822833 | 58 | F | NJ | 01/25/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
94se2 |
Immediate post-injection reaction, Injection site pain, Neuralgia, Pain
Immediate post-injection reaction, Injection site pain, Neuralgia, Pain
|
Immediate pain after the needle was being taken out of arm. The pain radiated down her arm to her ha...
Immediate pain after the needle was being taken out of arm. The pain radiated down her arm to her hand. She said she's been experiencing nerve pain for the last two months.
More
|
||||||
| 2822834 | 59 | M | CO | 01/25/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
TFAA2419 TFAA2419 |
Injected limb mobility decreased, Injection site pain, Magnetic resonance imagin...
Injected limb mobility decreased, Injection site pain, Magnetic resonance imaging abnormal, Muscular weakness, Myalgia; Shoulder injury related to vaccine administration, X-ray abnormal
More
|
Localized injection site pain for a few days, then the pain continued into the muscle of the shoulde...
Localized injection site pain for a few days, then the pain continued into the muscle of the shoulder/deltoid/upper arm. Pain continues to this day and is constant, 24/7. Went to Urgent Care, another doctor and ultimately this Dr. Celecoxib 200MG given for pain (which didn't help much). Strength in the left arm, flexibility and range of motion all limited since the shot. Dr called me a few days ago, Thursday 1.23.25, after the MRI/X-ray and confirmed my suspicion of SIRVA.
More
|
||||||
| 2822835 | 35 | F | FL | 01/25/2025 |
COVID19 |
MODERNA |
|
Headache, Nerve injury, Occipital neuralgia
Headache, Nerve injury, Occipital neuralgia
|
The being after I got Moderna vaccine I had a severe headache like I?ve never had before. It was mor...
The being after I got Moderna vaccine I had a severe headache like I?ve never had before. It was more than just a headache, it was severe stabbing pain in the back of my head on both sides. Pain level was 10/10, it felt like I got shot 3 times in the back of my head. Turns out the vaccine for some odd reason attacked the nerves in the back of my head and I?ve had occipital neuralgia (nerve damage) severe pain in my head ever since, non stop.
More
|
โ | |||||
| 2822841 | M | NM | 01/25/2025 |
HPV9 |
MERCK & CO. INC. |
|
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
|
Physician reported that he received Gardasil 9 off label years ago outside of age indication; No add...
Physician reported that he received Gardasil 9 off label years ago outside of age indication; No additional AE; This spontaneous report was received from Physician via Company representative, referring to himself. The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were unknown by the reporter. On an unspecified date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, , administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided). Physician reported that he received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) off label years ago, outside of age indication (Off label use in unapproved age group). No additional AE.
More
|
|||||||
| 2822842 | 17 | M | MO | 01/25/2025 |
HIBV MMR VARCEL |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
x024178 y004554 |
No adverse event, Product preparation error; No adverse event, Product preparati...
No adverse event, Product preparation error; No adverse event, Product preparation error; No adverse event, Product preparation error
More
|
HCP called to report that MMR II and VARIVAX were inadvertently reconstituted with PEDVAXHIB instead...
HCP called to report that MMR II and VARIVAX were inadvertently reconstituted with PEDVAXHIB instead of the STERILE DILUENT, and administered to the same patient. HCP stated this occurred between January 7, 2025 and January 13, 2025. Exact date was; No adverse effects were reported; HCP called to report that MMR II and VARIVAX were inadvertently reconstituted with PEDVAXHIB instead of the STERILE DILUENT, and administered to the same patient. HCP stated this occurred between January 7, 2025 and January 13, 2025. Exact date was; This spontaneous report was received from a nurse regarding a 12-month-old male patient. The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported. On an unknown date in January 2025 (reported as between 07-JAN-2025 and 13-JAN-2025), the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II) injection, 0.5 milliliter, lot #x024178, expiration date: 14-JUL-2025, and a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #y004554, expiration date: 20-FEB-2026 (strengths, doses, anatomical locations, and routes of administration were not reported), that were accidentally reconstituted with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5 milliliter (strength, lot #, expiry date, and route of administration were not provided) instead of sterile diluent; all were given as prophylaxis (Product preparation error) (Wrong product administered). No adverse effects were reported. Lot # was being requested and will be submitted if received.
More
|
||||||
| 2822843 | F | AZ | 01/25/2025 |
VARCEL |
MERCK & CO. INC. |
X002100 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
HCP did not report any side effects; female patient was administered an expired dose of the VARIVAX ...
HCP did not report any side effects; female patient was administered an expired dose of the VARIVAX vaccine on 01/20/2025. HCP stated that the VARIVAX vaccine expired on 01/19/2025; This spontaneous report was received from a certified medical assistant (CMA) concerning to a female patient of unspecified age. The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported. On 20-JAN-2025, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #X002100 (expiration date: 19-JAN-2025), administered for prophylaxis (strength, dose, anatomical location, and route of administration were not provided) (Expired vaccine used). However, the health care professional (HCP) did not report any side effects related to the administration of the expired dose of the vaccine and added that it did not have any prior temperature excursions (T.Es). HCP provided limited pertinent information and had no further clarifications to provide.
More
|
|||||||
| 2822844 | U | 01/25/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Herpes zoster, Pain, Vaccination failure
Herpes zoster, Pain, Vaccination failure
|
Suspected vaccination failure; got it 8 weeks after Shingrix shot/hurts; This serious case was repor...
Suspected vaccination failure; got it 8 weeks after Shingrix shot/hurts; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, 8 weeks after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got it 8 weeks after Shingrix shot/hurts). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK receipt date: 10-JAN-2025 This case was reported by a patient via interactive digital media. The patient reported that it hurts, got it 8 weeks after the Shingrix shot. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
More
|
||||||||
| 2822845 | 53 | M | TN | 01/25/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
|
Asthenia, Decreased appetite, Herpes zoster, Malaise, Nausea; Pyrexia, Rash, Ras...
Asthenia, Decreased appetite, Herpes zoster, Malaise, Nausea; Pyrexia, Rash, Rash pruritic, Somnolence
More
|
7 months after my second dose, in April 2024, I broke out with shingles. It was classic shingles, Le...
7 months after my second dose, in April 2024, I broke out with shingles. It was classic shingles, Left T9 dermatome, unilateral. Lasted ~10-14 days. I had a unilateral rash which was from my spine, around my left side around to my midline anteriorly. It did not progress upward or downward. It stayed in the dermatome band. I self treated and tolerated the pain and itchiness of the rash. However, toward the end of the 10-14 days, I developed fever of 102 and malaise. All I wanted to do was sleep, no energy, and didn't want to eat. I was not nauseous.
More
|
||||||
| 2822846 | 64 | M | NY | 01/25/2025 |
PNC20 |
PFIZER\WYETH |
|
Arthralgia, Pain, Product administered at inappropriate site
Arthralgia, Pain, Product administered at inappropriate site
|
I noticed that the injection was higher on my shoulder than usual. About 4 hours after receving th ...
I noticed that the injection was higher on my shoulder than usual. About 4 hours after receving th injection, I began experiencing sharp pain in my shoulder while working (using my arms). Pain slowly subsided over the next few days, but was still significant (5 out of 10 on my pain scale). It then began to increase and was aggravated by any normal use of my arm (work, exercise, yoga), particularly when reaching over shoulder height. OTC Ibuprofen is not helping. Began physical therapy (1 session so far). Pain yesterday and today is the worst it has been.
More
|
||||||
| 2822847 | 69 | F | SC | 01/25/2025 |
PNC21 PNC21 VARZOS VARZOS |
MERCK & CO. INC. MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
Y013009 Y013009 N77J2 N77J2 |
Chills, Cough, Headache, Lethargy, Lymphadenopathy; Malaise, Pyrexia; Chills, Co...
Chills, Cough, Headache, Lethargy, Lymphadenopathy; Malaise, Pyrexia; Chills, Cough, Headache, Lethargy, Lymphadenopathy; Malaise, Pyrexia
More
|
Patient called on 1/25/25 and said she has been feeling sick since the even evening the day she got ...
Patient called on 1/25/25 and said she has been feeling sick since the even evening the day she got the vaccines. She had received both the PCV 21and Shingrix. Shingrix was her second dose so she was emphasizing on the Pneumonia vaccine. At around 6 pm on the day of vaccination she started feeling sick. At midnight she had a fever of 103 and also getting chills. She reported of having swollen lymph nodes and headache. She had been taking tylenol to around the clock which was keeping the fever down but not totally off. She had started cough on 1/24 and felt lethargic the whole day on 1/24/25. on 1/25/25 she said her headache had gone down but cough was there.
More
|
||||||
| 2822848 | 0.25 | F | RI | 01/25/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
94369 94369 |
Fungal infection, Impaired work ability, Mobility decreased, Muscular weakness, ...
Fungal infection, Impaired work ability, Mobility decreased, Muscular weakness, Musculoskeletal disorder; Oral discomfort, Pain in extremity, Throat irritation
More
|
Initial burning mouth lips throat and fungal. Then loss of morning leg movements or functions someti...
Initial burning mouth lips throat and fungal. Then loss of morning leg movements or functions sometimes for hrs with excruciating pain. Leading to inability to report to work
More
|
โ | |||||
| 2822849 | 4 | M | TX | 01/25/2025 |
FLU3 HIBV |
SANOFI PASTEUR SANOFI PASTEUR |
UT8434LA UK107AB |
Rash; Rash
Rash; Rash
|
4 year old male. Administered HIB and Influenza vaccines. At the 15 minutes mark (1:20 pm) nurse ass...
4 year old male. Administered HIB and Influenza vaccines. At the 15 minutes mark (1:20 pm) nurse assessed patient for any reactions and seen that patient had a rash on right and left forearm. Small circle-like shape, brown in color, no elevation of skin. No rash anywhere else on the body. Dr. present and looked at patient. Intern listened to breathing. 1:27pm - Notified Dr., weighed patient (40lb - 18.18kg). Dr. advised to give 9mL of Benadryl. 1:36pm - Notified NM; DON, also present at site. 1:37pm - Vital Signs taken: T 97.9 axillary, P 135, R 26, B/P 91/80 1:38pm - 9mL of Benadryl administered by RN Patient waited for 15 minutes and VS were taken again and assessed. 1:48pm - P 102, B/P 105/78 1:49pm - Called Dr. back and notified of current Vital Signs. Provider stated that they were okay and patient could leave. Advised mother to monitor patient and if any new symptoms occurred to call EMS or take patient to Emergency Room. Mother verbalized understanding. Patient left with mother ambulatory. 4:02pm - Called to follow up with mother. She stated that patient was doing good and marks were getting lighter.
More
|
||||||
| 2822850 | 69 | F | GA | 01/25/2025 |
FLU3 |
SEQIRUS, INC. |
388477 |
Injection site discolouration, Injection site rash, Injection site swelling, Ras...
Injection site discolouration, Injection site rash, Injection site swelling, Rash pruritic
More
|
Patient first experienced a site reaction - it was red and puffy around the site of injection about ...
Patient first experienced a site reaction - it was red and puffy around the site of injection about two days after. A week later, a rash developed in the area that was itchiness and caused a slight skin discoloration that is still in the area.
More
|
||||||
| 2822851 | 11 | M | SC | 01/25/2025 |
MNQ MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
|
C-reactive protein increased, Haematocrit normal, Haemoglobin normal, Immunoglob...
C-reactive protein increased, Haematocrit normal, Haemoglobin normal, Immunoglobulin therapy, Injection site bruising; Nausea, Petechiae, Platelet count decreased, Vomiting, White blood cell count increased
More
|
vomiting, nausea, petechiae and bruising at the site. He was noted to have petechiae on the face, ne...
vomiting, nausea, petechiae and bruising at the site. He was noted to have petechiae on the face, neck, back and ankles. Given this labs were obtained and showed platelets of 10. Was admitted to the hospital and given IVIG due to concern for ITP
More
|
โ | |||||
| 2822852 | 68 | M | FL | 01/25/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
255T2 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
Duplicate vaccine with no side effects
Duplicate vaccine with no side effects
|
||||||
| 2822853 | 70 | F | WI | 01/25/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
8080803 8080803 |
Burning sensation, Chills, Fatigue, Headache, Mobility decreased; Muscle spasms,...
Burning sensation, Chills, Fatigue, Headache, Mobility decreased; Muscle spasms, Muscular weakness, Pain in extremity
More
|
As with every vaccine received, I develop an inflammatory response, mainly in my legs that is so sev...
As with every vaccine received, I develop an inflammatory response, mainly in my legs that is so severe, my legs are weak (can only go downstairs on my butt), both legs burn terribly, and this time both arms felt inflamed, and also upper arm pain caused difficulty to lift off the weighted blanket to try to get out of bed; it caused severe chills that this time gave me an upper trap spasm; moderate headache. It generally begins after ~12 hours following the vaccination. It lasted ~ 26 hours. I could do absolutely nothing but let it runs its course. The following day the inflammatory response had diminished in my legs but still felt a bit in my arms. Had a lot of fatigue the following day.
More
|
||||||
| 2822854 | 11 | M | KS | 01/25/2025 |
FLU3 |
SANOFI PASTEUR |
ut8506na |
Dizziness, Head injury, Syncope
Dizziness, Head injury, Syncope
|
Patient was walking with parent in OTC aisle and fainted. He says he remembers feeling light headed ...
Patient was walking with parent in OTC aisle and fainted. He says he remembers feeling light headed and then was on the ground. His dad was with him and pharmacy staff was notified. Paramedics were called to check for any signs of concussion since he did fall and hit his head. He was able to leave the store after the paramedics reviewed his condition.
More
|
||||||
| 2822855 | 65 | M | CA | 01/25/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
LM2212 U8507BA |
Mobility decreased, Pain, Pain in extremity; Mobility decreased, Pain, Pain in e...
Mobility decreased, Pain, Pain in extremity; Mobility decreased, Pain, Pain in extremity
More
|
Patient received COVID vaccine on October 5 and states that "a week and a half ago" in mid...
Patient received COVID vaccine on October 5 and states that "a week and a half ago" in mid-January he noticed a radiating pain in the arm where he received the vaccine. He states the pain is radiating from shoulder to elbow and he's having difficulty lifting his arm. I personally gave him the vaccine, and administered it into the deltoid muscle, not anywhere near the acromion process. He is also experiencing ongoing dizziness but is not sure if that is from the vaccine, or if it's from the COVID infection he had later in October. Patient will call his doctor on Monday.
More
|
||||||
| 2822856 | 67 | F | 01/25/2025 |
UNK |
UNKNOWN MANUFACTURER |
AREXVY |
Extra dose administered
Extra dose administered
|
Paient requested and was administered an AREXVY vaccine. It was then discovered that the patient had...
Paient requested and was administered an AREXVY vaccine. It was then discovered that the patient had already received a vaccine 2 years ago. Spoke with patient the following day and they are fine.
More
|
|||||||
| 2822857 | 40 | F | CO | 01/25/2025 |
FLU3 |
SANOFI PASTEUR |
|
Mass, Myalgia, Pain of skin, Skin burning sensation, Sleep disorder
Mass, Myalgia, Pain of skin, Skin burning sensation, Sleep disorder
|
Burning, painful, tender skin and muscles in left upper shoulder/neck area. Protruding painful lump ...
Burning, painful, tender skin and muscles in left upper shoulder/neck area. Protruding painful lump on left clavicle. Symptoms have continued without lessening, interrupting sleep.
More
|
||||||
| 2822609 | 16 | F | NY | 01/24/2025 |
HPV9 |
MERCK & CO. INC. |
|
Syncope
Syncope
|
Provider stated that she had a patient syncopize on exam table after a dose of gardasil 9 this past ...
Provider stated that she had a patient syncopize on exam table after a dose of gardasil 9 this past year. She said the patient remained alert and recovered. No injury noted.; This spontaneous report was received from Physician via Company Representative referred to a 16-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date in 2024, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, dose number, frequency, scheme, lot #, expiry date, route of administration, and anatomical location were not provided). On an unknown date in 2024, the reporter stated that she had a patient syncopize on exam table after the dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (syncope), and reported that the patient remained alert and recovered on an unknown date; it was also reported that no injury was noted. The reporter did not assess the causal relationship between the syncope and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection. Upon internal review syncope was determined to be medically significant event. Additional information is not expected.
More
|
||||||
| 2822610 | 0.17 | M | 01/24/2025 |
HEP |
MERCK & CO. INC. |
|
Inappropriate schedule of product administration, Product administered to patien...
Inappropriate schedule of product administration, Product administered to patient of inappropriate age
More
|
third dose received on 24-mar2004; 2nd dose received on 13-nov-2002; first dose received on 27-SEP-2...
third dose received on 24-mar2004; 2nd dose received on 13-nov-2002; first dose received on 27-SEP-2002; This spontaneous report was received from other health care professional from a medical record, from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (MARRS # 2501USA005583) and concerns male patient (transgender) of 11 weeks old. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 27-SEP-2002, the patient started therapy with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Inappropriate age at vaccine administration). On 13-NOV-2002, the patient received 2nd dose administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of vaccine administered) On 24-MAR-2004, the patient received the third dose administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of vaccine administered). This is one of two reports regarding the same patient.; Sender's Comments: US-009507513-2501USA005583:
More
|
|||||||
| 2822611 | U | 01/24/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
|
Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactiv...
Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 11-JAN-2025 This case was reported by a patient via interactive digital media. The patient had received both doses of shingles vaccine but after got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
More
|
||||||||
| 2822613 | 20 | F | PA | 01/24/2025 |
HPV9 |
MERCK & CO. INC. |
|
Burkitt's lymphoma, Chemotherapy
Burkitt's lymphoma, Chemotherapy
|
Burkitt?s Lymphoma, Intensive Chemotherapy lasting approximately 3 months
Burkitt?s Lymphoma, Intensive Chemotherapy lasting approximately 3 months
|
โ | |||||
| 2822614 | 65 | F | WA | 01/24/2025 |
CHIK |
VALNEVA USA, INC. |
|
Arthralgia, Headache, Joint swelling, Pyrexia, Rash
Arthralgia, Headache, Joint swelling, Pyrexia, Rash
|
On the date listed, rash all over back of ankles, swollen ankles, rash on arm joints. Prior days, h...
On the date listed, rash all over back of ankles, swollen ankles, rash on arm joints. Prior days, headaches, joint aches, fever 102 degrees.
More
|
||||||
| 2822618 | U | IL | 01/24/2025 |
HEP |
MERCK & CO. INC. |
|
Inappropriate schedule of product administration
Inappropriate schedule of product administration
|
No other AE; HCP reporting a 12 year old patient initiated the series on 02/05/2021 and the second d...
No other AE; HCP reporting a 12 year old patient initiated the series on 02/05/2021 and the second dose was not administered until 12/09/2024.; This spontaneous report was received from a physician and refers to a 12-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 05-FEB-2021, the patient was vaccinated with the first dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). On 09-DEC-2024, the patient was vaccinated with the second dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of product administration). The patient had not received the third dose or completed the series as of yet. No symptoms reported and no additional details provided. Confirmed no product or quality events to report. No other adverse event (AE) or product quality complaint (PQC) was reported.
More
|
|||||||
| 2822619 | U | 01/24/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
|
Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactiv...
Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 55-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (before the age of 50). On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 09-JAN-2025 This case was reported by a patient via interactive digital media. Patient stated that most likely, but he/she gotta use and shingles before 50 and got shingles shot and now he/she had it again at 55. Patient said it was awful. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, completion of primary vaccination schedule, time to onset of shingles and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
More
|
||||||||
| 2822620 | 43 | F | IL | 01/24/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
D4774 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
|
Late second dose; This non-serious case was reported by a pharmacist via call center representative ...
Late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 43-year-old female patient who received HAB (Twinrix) (batch number D4774, expiry date 12-SEP-2026) for prophylaxis. Previously administered products included Twinrix (1st dose received on 12th August 2024). On 02-JAN-2025, the patient received the 2nd dose of Twinrix. On 02-JAN-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late second dose). The outcome of the drug dose administration interval too long was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 02-JAN-2025 Pharmacist called to verify when the 3rd dose of Twinrix should be administered if the first dose was administered on 12th August 2024 and the second dose on 2nd January 2025. The vaccine administration facility is the same as primary reporter. The patient received second dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule. The case is linked with case US2025000310, reported by the same reporter for husband.; Sender's Comments: US-GSK-US2025000310:Same reporter/ Different patient (Husband case)
More
|
||||||
| 2822621 | 30 | M | WA | 01/24/2025 |
IPV IPV TDAP TDAP |
SANOFI PASTEUR SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
W1C71M W1C71M XN575 XN575 |
Anxiety, Dizziness, Dyskinesia, Immediate post-injection reaction, Loss of consc...
Anxiety, Dizziness, Dyskinesia, Immediate post-injection reaction, Loss of consciousness; Pallor, Posture abnormal, Seizure like phenomena; Anxiety, Dizziness, Dyskinesia, Immediate post-injection reaction, Loss of consciousness; Pallor, Posture abnormal, Seizure like phenomena
More
|
Anxiety, dizziness occurred immediately after 2nd vaccination (Boostrix) as the needle was retracted...
Anxiety, dizziness occurred immediately after 2nd vaccination (Boostrix) as the needle was retracted. He was advised to take a sip of his water, which he did After drinking some water, he immediately rolled his head back and started to have leg jerking movements, such as a seizure event. This lasted about 5 seconds and we immediately called 911. He gained consciousness within a few seconds. He sat and elevated his feet, but he did not recall any of the events after the vaccine for about 2 minutes. He was very pale so we offered more water and chocolate and cookies EMT took over after about 5 minutes.
More
|
||||||
| 2822666 | 6 | M | MD | 01/24/2025 |
COVID19 |
MODERNA |
NDC: 800777-029 |
Urticaria
Urticaria
|
My son (age 6) received his 4th Moderna COVID vaccine (2024-2025 booster- 3-11- .25 ML) at about 5 p...
My son (age 6) received his 4th Moderna COVID vaccine (2024-2025 booster- 3-11- .25 ML) at about 5 pm at a local pharmacy. He has not had reactions to the vaccine before. At 11 pm he woke us up and was covered in full body hives. We gave him benedryl and took him to the emergency room. The benedryl helped and he got no further treatment in the emergency room. He took zyrtec for a few days until the hives were gone. Follow up with pediatrician and allergist suggests this was an immune reactions. They do not recommend avoiding vaccines in the future, but perhaps switching brands.
More
|
||||||
| 2822667 | 70 | F | IA | 01/24/2025 |
COVID19 |
MODERNA |
3043159 |
Death
Death
|
Death
Death
|
โ | |||||
| 2822669 | 66 | F | VA | 01/24/2025 |
HEPA |
MERCK & CO. INC. |
X025484 |
Underdose
Underdose
|
Patient was given a Pediactric dose of a Hepatitis A vaccine instead of the adult dose.
Patient was given a Pediactric dose of a Hepatitis A vaccine instead of the adult dose.
|
||||||
| 2822670 | 1.33 | F | NC | 01/24/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK109AA |
Wrong product administered
Wrong product administered
|
Pentacel was given by mistake instead of ActHib. 15 month series includes Dtap, Hib, Pneumoconjugate...
Pentacel was given by mistake instead of ActHib. 15 month series includes Dtap, Hib, Pneumoconjugate. Daptacel, Pentacel, and Prevnar-20 were given.
More
|